Label: BLOWFISH- aspirin, caffeine tablet, effervescent

  • NDC Code(s): 75920-0464-1, 75920-0464-2, 75920-0464-4, 75920-0464-8
  • Packager: Rally Labs LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 21, 2017

If you are a consumer or patient please visit this version.

  • Active ingredients

    Aspirin 500 mg (NSAID*)
    Caffeine 60 mg

    *Nonsteroidal anti-inflammatory drug

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  • Purpose

    Aspirin…..Pain reliever
    Caffeine…Alertnes aid/Pain reliever aid

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  • Uses

    • for the temporary relief of minor aches and pains associated with a hangover
    • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
    • also for the temporary relief of headaches or body aches and pains alone
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  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)

    • shock

    Stomach bleeding warning:
    This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
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  • Do not use

    • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever inducer
    • in children under 12 years of age
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  • Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma
    • you have a sodium-restricted diet
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  • Ask a doctor or phamacist before use if you are

    taking a prescription drug for

    • diabetes
    • gout
    • arthritis

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  • When using this product

    • the recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, irritability, sleeplessness, and occasionally rapid heart beat.

    • for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to occur, consult a doctor.
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  • Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:

      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better 
    • pain lasts for more than 10 days or gets worse

    • new symptoms occur

    • redness or swelling is present

    • ringing in the ears or a loss of hearing occurs

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  • If pregnant or breastfeeding

    ask a health professional before use. It is especially important not to use aspiring during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • upon waking, fully dissolve 2 tablets in 16 oz. of water and drink
    • do not exceed recommended dosage
    Adults and children 12 years and over
    (up to 60 years of age)
    2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 8 tablets in 24 hours
    Adults 60 years and over 2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4 tablets in 24 hours
    Children under 12 years Do not use
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  • Other information

    • each tablet contains: sodium 406 mg
    • phenylketonurics: contains phenylalanine 12.6 mg per tablet

    • store at room temperature (59–86°F). Protect from excessive heat.

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  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

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  • Questions or Comments?

    1-800-970-1793 (weekdays)

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  • PRINCIPAL DISPLAY PANEL

    NEW!

    PAIN RELIEVER • ALERTNESS AID

    Contains Aspirin (NSAID) and Caffeine

    Blowfish ®

    for Hangovers

    12 EFFERVESCENT TABLETS

    P/N: 6039A R: 01/12

    Package Label

    DO NOT USE IF PRINTED PACKETS ARE TORN OR PUNCTURED

    Own the night.
    Save the day.

    WAKE up with a hangover.
    DROP Blowfish in water.
    DRINK when fizzing stops.
    FORGET your hangover.

    Distributed by Rally Labs LLC
    P.O. Box 20094, New York, NY 10014
    1-800-970-1793

    P/N: 6040A R: 01/12

    Package Label
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  • INGREDIENTS AND APPEARANCE
    BLOWFISH 
    aspirin, caffeine tablet, effervescent
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:75920-0464
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75920-0464-1 2 in 1 BOX; Type 0: Not a Combination Product 07/23/2011
    2 NDC:75920-0464-8 12 in 1 BOX; Type 0: Not a Combination Product 07/23/2011
    3 NDC:75920-0464-2 20 in 1 BAG; Type 0: Not a Combination Product 11/30/2017
    4 NDC:75920-0464-4 40 in 1 BAG; Type 0: Not a Combination Product 11/30/2017
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/23/2011
    Labeler - Rally Labs LLC (965453108)
    Establishment
    Name Address ID/FEI Business Operations
    Tower Laboratories Ltd 001587203 manufacture(75920-0464)
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